UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018627
Receipt number R000021555
Scientific Title The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study
Date of disclosure of the study information 2015/10/01
Last modified on 2020/08/14 11:55:17

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Basic information

Public title

The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study

Acronym

The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs

Scientific Title

The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study

Scientific Title:Acronym

The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs

Region

Japan


Condition

Condition

collagen diseases, kidney diseases, digestive diaseases, liver diaseases, neurological diseases, kidney transplant patients

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Assessment of antibody acquisition after vaccination classified by each virus.
2) Analysis of long maintenance of acquired immunity.
3) Analysis of incididence of adverse events.

Key secondary outcomes

1) Analysis of causes of vaccine failure.
2) Analysis of causes of adverse events.
3) Analysis of effect for prevention of virus infection.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Live attenuated vaccine

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

1 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Equal or more than one years old.
2. Patients under treatment with immunosuppressants(tacrolimus, cyclosporine, mizoribine, azathioprine, methotrexate mycophenolate mofetil)
3. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6).
4. Serum IgG level>300mg/dl
5. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps.
6. Patients under treatment with prednisolone <1mg/kg/day or <2mg/kg every alternate day.
7. tacrolimus trough level<10ng/ml or cyclosporine trough level<100ng/ml.
8. Patients with low activity of underlying disease.
9. Patients who cannot discontinue immunosuppressants because of primary disease.

Key exclusion criteria

1. Steroid use of more than 1mg/kg/d.
2. For renal transplant recipients, <1 year since transplantation or acute rejection within the previous 6 months.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Nishimura

Organization

Yokohama City University

Division name

Department of Pediatrics

Zip code

2360004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan

TEL

+81-45-787-2800

Email

k_nsm@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Nishimura

Organization

Yokohama City University

Division name

Department of Pediatrics

Zip code

2360004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan

TEL

+81-45-787-2671

Homepage URL


Email

k_nsm@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Pediatrics, Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Department of Pediatrics, Yokohama City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yokohama City University

Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan

Tel

+81-45-787-2800

Email

k_nsm@yokohama-cu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2015 Year 07 Month 09 Day

Date of IRB

2015 Year 10 Month 01 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry

2021 Year 07 Month 31 Day

Date trial data considered complete

2021 Year 08 Month 31 Day

Date analysis concluded

2021 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 10 Day

Last modified on

2020 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name